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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. AMBULATORY INFUSION PUMPS CADD ADMINISTRATION SETS - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD,INC. AMBULATORY INFUSION PUMPS CADD ADMINISTRATION SETS - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number SET, ADMIN, CADD, 108", SPIKE, 0.2 MICRON, FLTR,
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Information received a smiths medical ambulatory infusion pumps|cadd administration sets - flow stop filter is leaking medication.No patient adverse events reported.
 
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Brand Name
AMBULATORY INFUSION PUMPS CADD ADMINISTRATION SETS - FLOW STOP
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD,INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD,INC.
6000 nathan lane
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 lane n
minneapolis, MN 55442
7633833310
MDR Report Key11403472
MDR Text Key239349908
Report Number3012307300-2021-01673
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027536
UDI-Public10610586027536
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSET, ADMIN, CADD, 108", SPIKE, 0.2 MICRON, FLTR,
Device Catalogue Number21-7394-24
Device Lot Number4063438
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/03/2021
Initial Date FDA Received03/03/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/02/2020
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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